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Patient identifier and weight were unavailable from the attached journal article or by the authors.
Patient age and patient sex not made available the attached journal article or by the authors.
The article reports that the mean patient age was 59 and the consisted of female patients in the study.
Therefore 59 years old and female were used.
Event date is approximated.
Date provided is when the journal article was accepted.
Citation: yano s, hide t, & shinojima n.
Efficacy and complications of endoscopic skull base surgery for giant pituitary adenomas.
World neurosurg.
(2017) 99:533-542.
Http://dx.
Doi.
Org/10.
1016/j.
Wneu.
2016.
12.
068.
The exact system information could not be determined as it was not provided.
However, the system listed on this form was at the address listed in the article during the time some of the surgeries were completed.
Device udi not provided as actual product used for this study is unknown.
No parts have been received by the manufacturer for evaluation.
Device manufacturing date is dependent on lot number/serial number, therefore, unavailable.
No further information provided in the journal article or from the authors.
The author could not provide any additional information or insight as he was not at the site when the surgeries were performed.
No request for service have been received from the customer regarding these events.
No parts have been replaced or returned to the manufacturer for evaluation.
Medtronic navigation is filing this mdr to ensure visibility to a patient event as a result of a procedure that utilized medtronic navigation's surgical navigation system.
There is no allegation to suggest that medtronic navigation's device caused or contributed to the reported event.
Device not returned by customer.
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The journal article was forwarded by medtronic representative.
Article indicated the use of surgical navigation system.
Objective: we report surgical results and complications of endoscopic endonasal skull base surgery for giant pituitary adenomas.
Methods: this study included 34 pituitary adenomas >40 mm treated by endoscopic endonasal skull base surgery between 2002 and 2015.
Removal rates, symptoms, and complications were analyzed by direction of tumor extension.
Results: average tumor size was 45.
5 mm.
Near-total resection was achieved in 16 of 34 (47.
1%) cases.
Near-total resection was achieved significantly more often in anterior extension types and round tumor in superior extension types compared with multiple extension types.
The average residual amount in 18 partial resection cases was 30.
2% of preoperative volume, with no significant difference between groups.
Regrowth after partial resection occurred in 8 cases, but repeated surgery or stereotactic radiotherapy controlled tumor growth and improved symptoms.
Postoperative improvement of visual field deficits was achieved in 23 of 25 (92.
0%) cases.
Postoperative complications included visual deterioration (n [ 1), cerebrospinal fluid leakage (n [ 2), and cerebral infarction secondary to perforator injury (n [ 2).
Symptomatic intratumoral hemorrhage occurred in 1 multiple extension type.
Conclusions: endoscopic endonasal skull base surgery enables less invasive and safer removal of various extension types of giant pituitary adenomas.
Preservation of visual function is essential.
Two-stage surgery or partial resection with additional treatments is possible without complications if a sufficient amount of resection is performed.
In cases in which insufficient resection may be expected, alternative treatment, including combined simultaneous resection, should be considered.
Reported adverse event : 4 new anterior hormonal deficiency, 7 permanent diabetes insipidus, 2 csf leakage , 2 meningitis , 1 visual deterioration , 2 cerebral infarction , 1 hydrocephalus.
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